Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (M032-HSV-1)

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ClinicalTrials.gov Identifier: NCT02062827

Recruitment Status : Active, not recruiting

First Posted : February 14, 2014

Results First Posted : February 2, 2024

Last Update Posted : February 2, 2024

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Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

James Markert, MD, University of Alabama at Birmingham

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Recurrent Glioblastoma Multiforme Progressive Glioblastoma Multiforme Anaplastic Astrocytoma or Gliosarcoma
Intervention	Biological: M032 (NSC 733972)
Enrollment	29

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	10^5 Single Dose of HSV-1 (M032)	10^6 Single Dose of HSV-1 (M032)	10^7 Single Dose of HSV-1 (M032)	10^7.5 Single Dose of HSV-1 (M032)	10^8 Single Dose of HSV-1 (M032)	10^8.5 Single Dose of HSV-1 (M032)	10^9 Single Dose of HSV-1 (M032)	Screen Fails
Arm/Group Description	Participants were administered 10^5...	Participants were administered 10^6...	Participants were administered 10^7...	Participants were administered 10^7...	Participants were administered 10^8...	Participants were administered 10^8...	Participants were administered 10^9...	Participants that consented to the ...
Arm/Group Description	Participants were administered 10^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants that consented to the study, but ended up becoming ineligible before they were given M032
Period Title: Overall Study
Started	4	1	1	2	6	1	6	8
Completed	0	0	0	0	0	1	1	0
Not Completed	4	1	1	2	6	0	5	8
Reason Not Completed
Death	1	0	0	0	0	0	0	0
Withdrawal by Subject	3	1	1	2	6	0	5	0
Screen Fail	0	0	0	0	0	0	0	8

Baseline Characteristics

Arm/Group Title		10^5 Single Dose of HSV-1 (M032)	10^6 Single Dose of HSV-1 (M032)	10^7 Single Dose of HSV-1 (M032)	10^7.5 Single Dose of HSV-1 (M032)	10^8 Single Dose of HSV-1 (M032)	10^8.5 Single Dose of HSV-1 (M032)	10^9 Single Dose of HSV-1 (M032)	Screen Fails	Total
Arm/Group Description		Participants were administered 10^5...	Participants were administered 10^6...	Participants were administered 10^7...	Participants were administered 10^7...	Participants were administered 10^8...	Participants were administered 10^8...	Participants were administered 10^9...	Participants who consented, but bec...	Total of all reporting groups
Arm/Group Description		Participants were administered 10^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants were administered 10^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI	Participants who consented, but became ineligible prior to receiving M032	Total of all reporting groups
Overall Number of Baseline Participants		4	1	1	2	6	1	6	8	29
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants	1 participants	1 participants	2 participants	6 participants	1 participants	6 participants	8 participants	29 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	4 100.0%	1 100.0%	1 100.0%	2 100.0%	5 83.3%	1 100.0%	5 83.3%	7 87.5%	26 89.7%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 16.7%	0 0.0%	1 16.7%	1 12.5%	3 10.3%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	4 participants	1 participants	1 participants	2 participants	6 participants	1 participants	6 participants	8 participants	29 participants
		40 (48.45)	39 (48.45)	56 (48.45)	42.5 (48.45)	52.67 (48.45)	56 (48.45)	48.83 (48.45)	50 (48.5)	49.07 (48.45)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants	1 participants	1 participants	2 participants	6 participants	1 participants	6 participants	8 participants	29 participants
	Female	2 50.0%	0 0.0%	1 100.0%	0 0.0%	1 16.7%	1 100.0%	0 0.0%	2 25.0%	7 24.1%
	Male	2 50.0%	1 100.0%	0 0.0%	2 100.0%	5 83.3%	0 0.0%	6 100.0%	6 75.0%	22 75.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	4 participants	1 participants	1 participants	2 participants	6 participants	1 participants	6 participants	8 participants	29 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	4 100.0%	1 100.0%	1 100.0%	2 100.0%	6 100.0%	1 100.0%	6 100.0%	8 100.0%	29 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	4 participants	1 participants	1 participants	2 participants	6 participants	1 participants	6 participants	8 participants	29 participants
United States		4	1	1	2	6	1	6	8	29

Outcome Measures

1.Primary Outcome


Title	Maximum Tolerated Dose (MTD) of M032
Description	[Not Specified]
Description	[Not Specified]
Time Frame	baseline to12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Single Dose of HSV-1 (M032)
Arm/Group Description:	Participants were administered 10^5...
Arm/Group Description:	Participants were administered 10^5, 10^6, 10^7, 10^7.5, 10^8, 10^8.5, or 10^9 pfu of single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
Overall Number of Participants Analyzed	21
Measure Type: Number Unit of Measure: plaque-forming units (PFU)
	1000000000

2.Secondary Outcome


Title	Time to Progression Assessment
Description	[Not Specified]
Description	[Not Specified]
Time Frame	baseline to 12 months

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	The Time of Survival Assessment
Description	[Not Specified]
Description	[Not Specified]
Time Frame	baseline to 12 months

Outcome Measure Data Not Reported

4.Secondary Outcome


Title	The Time of Biologic Assessment
Description	[Not Specified]
Description	[Not Specified]
Time Frame	baseline to 12 months

Outcome Measure Data Not Reported

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	10^5 Single Dose of HSV-1 (M032)		10^6 Single Dose of HSV-1 (M032)		10^7 Single Dose of HSV-1 (M032)		10^7.5 Single Dose of HSV-1 (M032)		10^8 Single Dose of HSV-1 (M032)		10^8.5 Single Dose of HSV-1 (M032)		10^9 Single Dose of HSV-1 (M032)
Arm/Group Description	Participants were administered 10^5...		Participants were administered 10^6...		Participants were administered 10^7...		Participants were administered 10^7...		Participants were administered 10^8...		Participants were administered 10^8...		Participants were administered 10^9...
Arm/Group Description	Participants were administered 10^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI		Participants were administered 10^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
All-Cause Mortality
	10^5 Single Dose of HSV-1 (M032)		10^6 Single Dose of HSV-1 (M032)		10^7 Single Dose of HSV-1 (M032)		10^7.5 Single Dose of HSV-1 (M032)		10^8 Single Dose of HSV-1 (M032)		10^8.5 Single Dose of HSV-1 (M032)		10^9 Single Dose of HSV-1 (M032)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	4/4 (100.00%)		1/1 (100.00%)		1/1 (100.00%)		2/2 (100.00%)		6/6 (100.00%)		1/1 (100.00%)		4/6 (66.67%)
Serious Adverse Events Serious Adverse Events
	10^5 Single Dose of HSV-1 (M032)		10^6 Single Dose of HSV-1 (M032)		10^7 Single Dose of HSV-1 (M032)		10^7.5 Single Dose of HSV-1 (M032)		10^8 Single Dose of HSV-1 (M032)		10^8.5 Single Dose of HSV-1 (M032)		10^9 Single Dose of HSV-1 (M032)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0.00%)		0/1 (0.00%)		0/1 (0.00%)		1/2 (50.00%)		1/6 (16.67%)		1/1 (100.00%)		2/6 (33.33%)
Gastrointestinal disorders
Nausea & vomiting ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
General disorders
Fatigue ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Headache ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Nervous system disorders
Cerebral Herniation ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Coma ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Intracranial Infection - intradural ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Left Hemiplegia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Right Lower Extremity Monoplegia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Strokes, bilateral ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Aspiration ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Respiratory Insufficiency ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Worsening Papular, Pustular rash ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Surgical and medical procedures
Surgical wound not healing ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	1/1 (100.00%)	1	0/6 (0.00%)	0
Vascular disorders
Hyponatremia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Edema Left ankle/foot ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Hypertension ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	1/1 (100.00%)	1	0/6 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	10^5 Single Dose of HSV-1 (M032)		10^6 Single Dose of HSV-1 (M032)		10^7 Single Dose of HSV-1 (M032)		10^7.5 Single Dose of HSV-1 (M032)		10^8 Single Dose of HSV-1 (M032)		10^8.5 Single Dose of HSV-1 (M032)		10^9 Single Dose of HSV-1 (M032)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100.00%)		0/1 (0.00%)		0/1 (0.00%)		2/2 (100.00%)		6/6 (100.00%)		1/1 (100.00%)		6/6 (100.00%)
Blood and lymphatic system disorders
Leukocytosis ^†	1/4 (25.00%)	2	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Cardiac disorders
Tachycardia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Ear and labyrinth disorders
Ear Infection ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	1/1 (100.00%)	1	0/6 (0.00%)	0
Right side eye and cheek swelling ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Yellow/Brown drainage left ear ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Eye disorders
Bilateral nystagmus ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Blurred Vision ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)
Constant black floaters ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Corneal abrasion ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Decreased visual field left eye, left side ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Diplopia ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Itching/dry eyes ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Left eye double vision ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Quadrantanopia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Visual field deficit left ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Gastrointestinal disorders
Bowel incontinence ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Constipation ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	2/6 (33.33%)	3	0/1 (0.00%)	0	0/6 (0.00%)	0
Diarrhea ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Emesis ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Fecal incontinence ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Nausea & vomiting ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	1/1 (100.00%)	1	0/6 (0.00%)	0
General disorders
Body Aches ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Chills ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Chest Pain ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Left arm & Right leg pain ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Left lower extremity weakness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Left side weakness ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	1/6 (16.67%)	1
Pain & swelling L foot/ankle gout flare up ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Right hip joint pain ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Runny nose ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	2/6 (33.33%)	2
Sinus Congestion ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Sleepiness ^†	0/4 (0.00%)	0	0/1 (0.00%)		0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Somnolence ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	1/6 (16.67%)	1
Sore throat ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Word finding difficulty ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Injury, poisoning and procedural complications
Crush injury to right elbow ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Fall ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	3/6 (50.00%)	4	0/1 (0.00%)	0	2/6 (33.33%)	3
Metabolism and nutrition disorders
Anorexia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Hyponatremia ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Hypernatremia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Musculoskeletal and connective tissue disorders
Left ankle sprain ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Left lower extremity muscle weakness against resistance ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Muscle weakness right side ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Nervous system disorders
Aphasia ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	2/6 (33.33%)	2
Ataxia ^†	1/4 (25.00%)	2	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
BUE tremors ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Decreased fine motor movement ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Dizziness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	2/6 (33.33%)	2	0/1 (0.00%)	0	0/6 (0.00%)	0
Dysesthesia ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Fine motor slowing right hand ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Gait Disturbance ^†	3/4 (75.00%)	5	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Increased left sided weakness ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Left facial weakness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Left upper extremity weakness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)
Left side proprioception ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Lose of Balance ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	2
Right facial droop ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Right hand weakness ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Right lower extremity weakness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Right upper extremity weakness ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Spasms ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Tingling LLE ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Worsening balance, coordination and right side weakness ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Worsening hemiparesis, left ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Psychiatric disorders
Insomnia ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Renal and urinary disorders
Enuresis ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Increased blood urea nitrogen ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Urinary flow issues ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Urinary incontinence ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Urinary Retention ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Epistaxis ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Classic Candida Rash to groin ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Itching/Rash ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Non-pruritic red raised pustule rash on face, chest and back ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Petechia left arm ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Psoriasis - worsening ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Rash to arms ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	1/2 (50.00%)	1	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Redness to arms and legs ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Skin discoloration red area back & abdomen ^†	1/4 (25.00%)	1	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	0/6 (0.00%)	0
Vascular disorders
Bruising ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	1/6 (16.67%)	1	0/1 (0.00%)	0	0/6 (0.00%)	0
Elevated blood pressure ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	1/6 (16.67%)	1
Hypertension ^†	0/4 (0.00%)	0	0/1 (0.00%)	0	0/1 (0.00%)	0	0/2 (0.00%)	0	0/6 (0.00%)	0	0/1 (0.00%)	0	2/6 (33.33%)	3
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	James Markert, MD
Organization:	The University of Alabama at Birmingham
Phone:	(205) 934-7171
EMail:	jmarkert@uabmc.edu

Layout table for additonal information

Responsible Party:	James Markert, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT02062827
Other Study ID Numbers:	UAB-1317 R01CA217179 ( U.S. NIH Grant/Contract )
First Submitted:	February 9, 2014
First Posted:	February 14, 2014
Results First Submitted:	October 5, 2023
Results First Posted:	February 2, 2024
Last Update Posted:	February 2, 2024

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